Bionnovation

FDA UDI

Class I (US FDA UDI)

by Bionnovation Produtos Biomedicos Ltda.

Identity

Trade Name: BIONNOVATION FDA UDI
Generic Name: Pin/post dental drill bit FDA UDI
Device Name: TWIST DRILL1,4 X 15 MM FDA UDI
Model / Reference: 05055 FDA UDI
Description: TWIST DRILL1,4 X 15 MM FDA UDI

Identifiers

Catalog Number: 05055 FDA UDI
Primary DI / UDI-DI: 07898628611028 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Pin/post dental drill bit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Pin/post dental drill bit

Bionnovation by Bionnovation Produtos Biomedicos Ltda. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MACRO-LOCK FINISHING DRILL 3 — RECHERCHES TECHNIQUES DENTAIRES · Class I
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GLASS FIBRE POST — Cynosure, LLC · Class I
Zuga — Zuga Medical, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bionnovation Produtos Biomedicos Ltda.

Sources (1)

FDA UDI 5bf17a23-94ff-4c9a-ab93-d30f37999bd2 34 fields · synced May 30, 2026